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Developed by:
U-MIC

2. significant and nonsignificant risk devices
in human subjects research
Developed by:
U-MIC
University of Michigan IRB Collaborative

3. significant risk device
Significant and nonsignificant risk devices
significant risk device
Significant risk device means an investigational device that:
Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Developed by:
U-MIC

4. significant risk device
Significant and nonsignificant risk devices
significant risk device
Significant risk device means an investigational device that:
Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Developed by:
U-MIC

5. nonsignificant risk device
Significant and nonsignificant risk devices
nonsignificant risk device
A nonsignificant risk device study is one that does not meet the definition for a significant risk device study.
Developed by:
U-MIC

6. diagnosing curing mitigating treating
Significant and nonsignificant risk devices
diagnosing
curing
mitigating
treating
may be
significant
(presents a potential for serious risk) or
nonsignificant
(does not present a potential for serious risk)
Developed by:
U-MIC

7. significant risk device
Significant and nonsignificant risk devices
significant risk device
intraocular lens
implanted surgically
presents a potential for serious risk
nonsignificant risk device
daily-wear contact lens
worn on eye’s surface
does not present a potential for serious risk
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U-MIC

8. FDA’s determination IRB’s determination
Significant and nonsignificant risk devices
FDA’s determination
supersedes both sponsor’s and IRB’s determinations
IRB’s determination
supersedes sponsor’s determination
sponsor’s determination
included, with rationale, in IRB application
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U-MIC

9. 21 CFR 812 significant risk device studies
Significant and nonsignificant risk devices
significant risk device studies
21 CFR 812
investigational device exemption (IDE)
FDA approves IDE
IRB approves study
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U-MIC

10. 21 CFR 812 .2(b) nonsignificant risk device studies
Significant and nonsignificant risk devices
nonsignificant risk device studies
21 CFR 812
abbreviated device study regulations
labeling
IRB approval
informed consent
monitoring
FDA-approved IDE not required
IRB serves as FDA surrogate
.2(b)
records
reports
prohibition against promoting or marketing
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U-MIC

11. IRB review Significant and nonsignificant risk devices
device and proposed use of device
convened IRB meeting
relevant information
description
past research
study plan
subject selection
meeting minutes should indicate determination
rationale
documentation
IDE approval letter
FDA’s nonsignificant risk determination
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U-MIC

12. IRB review expedited review of device studies
Significant and nonsignificant risk devices
IRB review
nonsignificant risk
applies only to device studies
expedited review of device studies
nonsignificant risk device study
minimal risk study
minimal risk
criterion for expedited review
Developed by:
U-MIC

13. IRB review study review and approval
Significant and nonsignificant risk devices
IRB review
study review and approval
risk/benefit assessment
significant or nonsignificant risk device determination
before study review and approval
potential harm of device or its use
Developed by:
U-MIC

14. significant nonsignificant risk device studies
Significant and nonsignificant risk devices
significant
nonsignificant
risk device studies
Developed by:
U-MIC

15. thank you.
Brian Seabolt
IRBMED
Developed by:
U-MIC